Antibacterial Drug Development Task Force

Antibacterial Drug Development Task Force

The CDER Antibacterial Drug Development Task Force has been created to support the development of new antibacterial drugs. This multi-disciplinary group, comprised of scientists and clinicians from throughout CDER, will work with other experts from academia, regulated industry, professional societies, patient advocacy groups, and government agencies to jointly promote antibacterial drug development.

The goals of the task force are to:

Explore novel scientific approaches to facilitate antibacterial drug development, such as the broader use of clinical pharmacology data, Bayesian methods, innovative clinical trial designs, utilization of additional available data sources, and the advancement of alternative measures to evaluate clinical effectiveness of potential new therapies.

Identify issues related to unmet medical needs for antibacterial drugs, reasons for the lack of a robust pipeline for antibacterial drug development, and new approaches for weighing the risks, benefits, and uncertainties of potential new antibacterial drugs.

Evaluate existing FDA guidances related to antibacterial drug development, determine if revision or further elaboration is needed, and identify areas where future guidance would be helpful.

Participate in think tanks with other thought leaders to address various issues that could enable antibacterial drug development, including study design, statistical analytical methods, and approval pathways.